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Colleen Moretti, Assistant Editor for CURE®, joined MJH Life Sciences in November 2020. Colleen is a graduate of Monmouth University, where she studied communication with a focus in journalism and public relations. In her free time, she enjoys learning to cook new meals, spending time with her adopted beagle, Molly, or sitting on the beach with a good book. Email her at cmoretti@curetoday.com
Front-line treatment with Opdivo plus Cabometyx improved health-related quality of life outcomes in patients with advanced renal cell carcinoma.
Treatment with Opdivo (nivolumab) plus Cabometyx (cabozantinib) in patients with advanced renal cell carcinoma (RCC) resulted in improved health-related quality of life, compared to treatment with Sutent (sunitinib).
Moreover, data presented at the 2021 American Society of Clinical Oncology Genitourinary Cancer Symposium showed that patients treated with the combination experienced a delay in deterioration and a significant decreased risk for confirmed deterioration in health-related quality of life scores, including disease-related kidney cancer symptoms.
“These results indicate that the superior clinical efficacy of (Opdivo plus Cabometyx) over (Sutent) is accompanied by the additional benefit of better (health-related quality of life,” the study authors wrote. “Moreover, the (health-related quality of life) outcomes also support the acceptable tolerability profile of the (Opdivo plus Cabometyx) combination for patients with advanced (health-related quality of life).”
In the phase 3 CheckMate 9ER trial, after a median follow-up of 18.1 months, Opdivo plus Cabometyx demonstrated superior progression free survival (the time from treatment to disease progression or worsening), overall survival (the period of time patients on a trial are still alive after they are diagnosed or started treatment) and objective response rate (the proportion of patients who had a complete or partial response to treatment), compared with Sutent, in patients with advanced RCC with a clear cell component.
In their presentation, the study authors investigated patient-reported health-related quality of life outcomes further, including overall between-group comparisons of treatment groups and time to confirmed deterioration outcomes.
“In addition to the clinical outcomes, analyses of (health-related quality of life), including time to confirmed deterioration in patient-reported outcome scores may provide important insights for clinicians to assess the benefit/risk profile of potential new treatment regimens,” they wrote.
To be eligible for the phase 3 trial, patients had to have previously untreated, advanced or metastatic RCC; a clear cell component; and any disease risk assessed by a database.
In total, patients were randomized 1:1 to receive either 240 milligrams IV of Opdivo every two weeks plus 40 milligrams of oral Cabometyx daily (323 patients) or 50 milligrams of oral Sutent for four weeks on, two weeks off (328 patients), until disease progression or toxicity.
Patient-reported outcome instruments were administered before treatment. At the time of enrolling onto the trial, 93% or more of patients in both treatment arms completed the patient-reported outcome requests, and completion rates remained at 80% or more through week 91.
Changes from the time patients enrolled onto the study to when the data were collected demonstrated that disease-related scores favored those who received the combination.
There was also a significant decreased risk of confirmed deterioration within the Opdivo and Cabometyx treatment arm.
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